1. Field of the Invention
This invention relates to condom articles, and methods for making and using same.
2. Description of the Related Art
In recent years, there has been a significant increase in the incidence and spread of sexually transmitted diseases (STD's). This increase in the incidence and rate of transmission of STD's is associated in part with the development of increasingly antibiotic-resistant strains of disease-causing organisms, e.g., those responsible for diseases such as syphilis and gonorrhea, as well as the absence of any effective cure for acquired immunodeficiency syndrome (AIDS).
Against this background, and the recognition that condoms afford a safe, low cost, and generally reliable means for combatting the spread of STD's, including AIDS, in addition to their traditional function as a barrier-type contraceptive device, the use of condoms has substantially increased in recent years.
Concurrently, most condoms are produced from a latex resin via a dipping process in which a cylindrical rounded-end mold is dipped in a resin bath, so that the mold is coated with a thin layer of the latex rubber material. The thickness of the latex coating on the mold is dependent on the viscosity of the latex, and the speed of extracting the mold from the latex bath. Similar latex dipping processes have been employed with suitably shaped molds to form tight-fitting articles such as surgical gloves.
The above-identified latex resin dipping process has been utilized for decades, and yields a generally satisfactory barrier product at reasonable cost.
With the recent spread of AIDS in the general population and the resurgence of condom usage in sexual activities, there has been interest in improving the strength and reliability characteristics of condoms, and of achieving improvements in manufacturing processes and economics for commercial production of condoms.
Structurally, the conventional latex condom comprises a tubular main sheath with a closed distal end and an open proximal end. The open proximal end of the condom may be circumscribingly bounded by a filament of elastic material, to aid in retaining the condom on the penis of a wearer, to demarcate the proximal opening for use of the condom, and to prevent tearing of or damage to the tubular main sheath of the condom during its application and use. To the extent that this elastic filament bears compressively against the circumference of the base of the penis, a further enhanced protection is provided against leakage of seminal fluid and sperm from the condom, and against entry of vaginal exudates or other coital secretions of the other coital partner into the interior volume of the condom containing the penis during sexual activity.
In order to accommodate the sealing and retention function of the elastic filament at the proximal opening of the condom, the elastic filament must be significantly stretched in application of the condom to the penis of the wearer. Thus, the condom is often difficult for the user to don, due to the small size of the condom's proximal opening, and the resistance to stretching of the proximal opening and the bounding filament which is intended to provide a tight fit once the condom is installed on the penis of the wearer.
During their commercial production, condoms made of latex rubber typically are rolled to render them easier to package, store, and apply, relative to unrolled condoms. Although rolling gives the condom a more compact structure, thereby facilitating ease of packaging and storage, the donning of rolled condoms frequently is difficult since the user must stretch the roll apart in the donning operation. Generally the "spreadability" of the rolled condom is made difficult by its tightly compacted character, and the required positioning of the rolled condom on the invariably asymmetric glans of the penis to initiate unrolling.
Further, the roll portion of the condom initially must be grasped with the fingers for application to the glans and unrolling onto the penis. The size of the condom roll is typically sufficiently small, e.g., generally being less than about 3/16 inch in roll diameter, so that it is difficult to grasp the roll with the fingertips and install the condom on the penis. This is particularly true in the case of very thin or form-fitting condoms which are characterized by a very tiny roll. As a result of the small size (diameter) of the roll, the need to utilize the fingers in installation of the condom, and the absence of any good grippability, the fingertips often are tightly pinched onto the roll to gain purchase thereon. This in turn raises the risk of shredding or puncturing of the condom material by the fingernails or otherwise breaking the condom as a result of such pinching or grasping, so that the condom, when subsequently unrolled, has breaks or discontinuities therein which render the condom deficient or even useless for its intended function.
The foregoing deficiencies of manual grippability of the condom and its susceptibility to damage during its installation are further exacerbated when, as is frequently the case, the condom is provided in lubricated condition. Most condoms are provided with a lubricant coating thereon, and such lubrication can render the condom extremely difficult to grasp prior to and during donning thereof.
The problems described above become even more acute when the user of a condom attempts to locate the proximal opening of the condom and to don the condom in darkened or low lighting environments in which it is difficult to visually ascertain the proper alignment of the condom. An inexperienced user, in particular, frequently attempts to unroll the condom in the wrong direction, and this may also occur even in circumstances where visual inspection of the condom is possible. Such misalignment further increases the risk that the condom may be broken or damaged by its mishandling.
An additional problem resulting from an initial attempt to unroll the condom in the wrong direction, before it is unrolled in the proper direction and installed on the penis of a wearer, is that the original mis-orientation brings the condom surface into contact with the glans of the penis, and this "contacted" surface subsequently, when the condom is properly installed, is on the exterior surface of the condom. Such contacted surface portion of the condom thus may bear disease-causing organisms, as well as seminal fluid, thereby creating a risk of disease transmission and contraceptive failure, and thereby obviating the advantages of condom usage.
An additional shortcoming of present condoms in many instances is the inadequacy of lubrication supplied thereon. As mentioned, most condoms are provided with a lubricant coating thereon, with the amount of lubrication being such as to facilitate vaginal penetration but not so much as to be inconvenient or messy to the user. Frequently, particularly during prolonged intercourse, the condom lubrication dries out or is otherwise dissipated, rendering the subsequent coital activity painful for the recipient sexual partner, and creating or increasing the risk of a break or tear in the condom. In other circumstances, couples engaged in coital activity may want or require additional lubrication. A wide variety of personal lubricants is available, but such lubricants are frequently inconvenient or messy to apply.
Although latex rubber materials have been widely used in the fabrication of condoms, and permit an economical manufacture of condoms to be achieved, latex rubber generally has the disadvantage that it is susceptible to oxidation, aging, and temperature, so that the shelf life of latex rubber condoms, particularly in the tropics, is generally less than desired. Further, latex rubber condoms are highly susceptible to breaking in a significant percentage of cases (estimates variously range from about 3% to about 10% or more, depending on the specific latex material employed in a given condom, the manufacture, processing, age, etc. of the condom, and the circumstances of its application and use).
In an effort to remedy these deficiencies, the art has given consideration to the fabrication of condoms from a variety of synthetic polymeric materials. Relative to latex rubber, synthetic polymeric materials afford substantial potential improvement in the strength and stability characteristics of condoms constructed of same.
Robert G. Wheeler U.S. Pat. No. 4,964,416 issued Oct. 23, 1990, discloses condoms formed of thermoplastic elastic materials such as thermoplastic elastomers, e.g., polyurethanes, polyesters, polyethers, polyether block amides, multiblock rubber-based copolymers, and other elastomeric homopolymers and copolymers, as well as non-elastomeric materials such as olefinic homopolymers and copolymers, e.g., ultra-low density polyethylene. The condoms disclosed in this patent may be of generally cylindrical shape, or alternatively may be formed as a baggy-type or pouch-type enclosure, which is wrapped about the penis for use. The baggy- or pouch-type condoms are retained on the penis in relatively looser configuration than are condoms of generally cylindrical shape which closely overfit the penis, and are rolled or pulled onto the penis for use.
Thermoplastic condoms are also variously disclosed in the art, in the following patents and publications: M. F. Dyke U.S. Pat. No. 4,576,156 issued Mar. 18, 1986 (condom formed of thermoplastic polyurethane material, having a generally cylindrical configuration); European patent application No. 0 147 072 published Jul. 3, 1985 in the names of Robert A. Taller, et al (a polyurethane condom formed by dipping of a mandril into a polyurethane prepolymer solvent solution, followed by heat curing on the mold); L. Hessel U.S. Pat. No. 4,735,621 issued Apr. 5, 1988 (a tubular protective (condom-like) device comprising a flexible, thin-walled tube closed at one end and having at an open end a collar-shaped, outwardly extending portion with means for radially stretching the collar or open end, and formed of natural or synthetic polymers including polyethylenes, polyurethanes, and derivatives thereof); and R. Sorkin U.S. Pat. No. 4,955,392 issued Sep. 11, 1990 (condom of elastic film material composed of a vulcanized blend of thermoplastic elastomer with a low modulus polyolefin such as a low-density polyethylene).
Even though, as shown by the above-described publications, condoms of synthetic polymeric materials have been proposed in the art, such condoms have not come into widespread commercial use, despite the technological capability which exists to produce polymeric sheet and film materials in tonnage (commodity) quantities.
A not uncommon occurrence in coital activity, depending on the anatomy of the partners and the type and character of the coital activities involved, is the incidence of abrasive contacts or impacts of the pubic bones of the respective coital partners against one another, which can physically and psychologically detract from the enjoyment of the coital activity. To remedy such occurrences, the coital partners may interpose hands, pillows, cushions, or the like between their respective contacting groin regions, however this is generally unsatisfactory, and may interfere with or eliminate significant penile penetration, resulting in diminished pleasure and satisfaction in the coital activity.
It would therefore be a significant advance in the art to provide a condom article which overcomes the foregoing various deficiencies, and which may be fabricated of synthetic polymeric materials or conventional latex rubber materials.
Relative to the condom articles, and methods of making and using the same which constitute various aspects of the present invention, related art is described below.
D. M. Robichaud U.S. Pat. No. 4,794,920 discloses a birth control device comprising an oversized sheath fitting loosely about the male organ, with a flange about the open end of the sheath for retaining the open end of the device outside the coital recipient partner's body. The sheath is formed of thin flexible impermeable material which is sized to fit loosely about the erect male organ thereby enabling movement of the male organ relative to the sheath during coitus, with the sheath being conformable to the shape of the vagina upon insertion therein.
H. A. Omley U.S. Pat. No. 4,484,918 issued Nov. 27, 1984 discloses a method and tool for applying a urine receptacle snugly on the penis of a wearer. The device comprises an elastic ring which is expanded to slide over the shaft of the penis without contacting it. The elastic ring then is relaxed and caused to return to a normal position, and the funnel-shaped end of a resilient catheter is slid over the penis and ring with the catheter gripping the outside of the ring in a leak-proof manner.
A. J. Conway, et al, U.S. Pat. No. 4,479,910 issued Oct. 9, 1984 describes a male condom catheter comprising a laminated sheath having an inner layer of latex rubber and an outer layer of silicone rubber, with adhesive therebetween. By this arrangement, the adhesive is released as the sheath is unrolled and adheres to the inner layer for adhesive attachment to the penis.
M. P. Poncy, et al, U.S. Pat. No. 4,275,812 issued Jun. 30, 1981, describes a surgical glove package which is stated to facilitate donning of a surgical glove. In the package, the cuff of each surgical glove is contained in a cylindrical ring with the cuff of the glove stretched around the ring to hold the glove open for donning. A bag is provided with its mouth sealed around the ring and enclosing the outer surface of the glove to maintain sterility prior to its use. In the donning operation, the hand is inserted through the ring into the glove and then the cuff of the glove is released from the ring. The ring then is removed from the hand so as to turn the bag inside out as the ring passes over the hand; the bag remains between the hand and the ring as the ring passes over the hand.
M. W. McGlothlin, et al, U.S. Pat. No. 4,855,169 issued Aug. 8, 1989 describes a prophylactic device having a sheath of elastomeric sheet material with a 100% tensile modulus of at least about 200 psi and a thickness of less than about 0.0014 inch. The sheath has an open end and a border containing a resilient material of reduced 100% tensile modulus, relative to the elastomeric sheet material. In this device, the ratio of the thickness of the border to the thickness of the sheath is from about 10 to about 300. The materials disclosed in the patent for the sheath include polyurethane and various other thermoplastic elastomeric materials. The patent discloses that the border may be constituted by a ring which is either bonded, or unbonded to the sheath.
It is an object of the present invention to provide a condom which may be advantageously formed of synthetic polymeric materials as well as conventional latex rubber materials, and which is characterized by greater ease of application to the penis of a wearer, as compared to conventional condoms.
It is another object of the present invention to provide a condom of the foregoing type, which is readily rolled for packaging and storage, in a manner which facilitates the installation of the condom on the penis of a wearer.
It is a further object of the invention to provide a condom fabricated from thin non-elastic polymeric film material, which may be utilized at film thicknesses lower than those heretofore believed feasible.
It is yet another object of the invention to provide a condom comprising means for cushioning and/or stimulation purposes, for enhancement of sexual pleasure of a recipient coital partner.
It is a still further object of the present invention to provide a method of making a condom of the foregoing type.
It is another object of the invention to provide a method of donning a condom which is superior to heretofore known methods.
It is yet another object of the present invention to provide a condom device furnishing selectively enhanced lubrication for coital activity.
Other objects and advantages of the present invention will be more fully apparent from the ensuing disclosure and appended claims.